Equipment & Process Technician III (1:30 pm-10 pm)

American Regent, Inc.; New Albany (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

American Regent, Inc. is seeking an Equipment and Process Technician III to support sterile pharmaceutical inspection and packaging operations. You will work with the Inspection and Packaging Supervisor to ensure schedules are met and records are accurate.

The role requires ability to troubleshoot automated equipment, perform setup and changeovers, and contribute to process improvement with Lean Six Sigma approaches. Strong teamwork and communication are essential.

Qualifications

• High School Diploma or GED required or equivalent.
• Technical Training or Bachelor’s Degree a plus.
• Minimum 4 years’ experience in inspection, packaging, quality control and/or production preferred.
• Ability troubleshoot basic operations on automated inspection machines.
• Must be able to recognize visual trends in automated inspection processes.

Responsibilities

• Physically performs inspection and packaging activities per SOPs and supervisor directions.
• Maintains accurate records and training records.
• Sets up and programs automated inspection and packaging equipment with minimal assistance.
• Supports changeovers, cleaning, and documentation oversight.
• Performs root cause analysis and participates in cross-functional teams.

Skills

Inspection

Packaging

Quality control

Production

Written communication

Mathematical skills

Troubleshooting

Lean Six Sigma

Education

High School Diploma or GED

Technical Training or Bachelor’s Degree

Tools

HMI-PLC/SCADA

Excel

Job description

Equipment and Process Technician III

Nature and Scope The Equipment and Process Technician III works with the Inspection and Packaging Supervisor in the activities associated with the inspection and packaging of sterile pharmaceuticals in accordance with company procedures and cGMPs. The incumbent meets inspection and packaging schedules while maintaining accurate records and professional behavior within the inspection/packaging areas. The Technician will perform inspection area setup, of automated equipment and manual inspection processes, labeling and packaging equipment and process duties, line clearances and assist with inspection/packaging schedule. The Technician will be responsible for maintaining inspection and packaging equipment for changeover and adjustments. In conjunction with the Supervisor, the Technician will provide input and assistance to other Departments as needed. The Technician plays a critical role in assuring safe, effective and compliant activities are performed in the inspecting and packaging area and plays a critical role in maintaining production schedules. The Equipment and Process Technician II will be proficient in all activities associated with the inspection and packaging process and be able to work with minimal supervision. The Technician will receive direction, training, and mentorship from the Supervisor of Inspection and Packaging. The Technician will with assistance from the Supervisor, be able to troubleshoot minor equipment adjustments and repairs during setup and during operations. The Technician will be able to select parameters requiring Supervisor Approval from some manufacturing technologies using the HMI-PLC/SCADA control/data systems. In addition, this role includes SPC data collection, Control chart evaluation and process improvement initiatives. This role will allocate time for cross functional team participation and root cause analysis.

Essential Duties and Responsibilities

• Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.
• Physically performs inspection and packaging activities as defined by established operating procedures and as directed by Manager/Supervisor.
• Maintains accurate and complete records.
• Maintains an accurate and complete Training Record.
• Ability to set-up and program automated Inspection and Packaging equipment with little to no assistance.
• Physically performs inspection, packaging, changeover, cleaning and provides documentation oversight for all such activities.
• Physically performs inspection and packaging reconciliation and provides documentation oversight and acknowledgement for such activities.
• Assists with training of new personnel within the department.
• Ability to mentor other Technicians in all facets of the inspection process.
• Ability to assist the Supervisor in the planning of inspection and packaging activities on a daily, weekly and long term schedule.
• Ability (in conjunction with Supervisor) to assign equipment, rooms or personnel to meet required production schedule.
• Ability to troubleshoot any problems that might arise.
• Ability to review executed batch records and log books prior to submitting for final Production review.
• Provides accurate and complete assistance to Quality Assurance as needed.
• Works in a safe and effective manner.
• Identifies and reports unsafe and non-compliant conditions.
• Maintains work space in a clean and orderly manner.
• Participate in Cross-functional team participation.
• Ability to perform Root Cause Analysis.
• Ability to execute tasks in a Inventory Management System.
• Apply Lean Six Sigma learnings to current processes within the department and organization.
• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

High School Diploma or GED equivalent preferred.

Technical Training or Bachelors’ Degree is a plus.

Minimum 4 years’ experience in inspection, packaging, quality control and/or production preferred.

Ability troubleshoot basic operations on automated inspection machines to include, jams, basic error codes, etc.

Must be able to recognize visual trends in automated inspection process and elevate as necessary.

Must be able to work independently, completing assigned tasks with limited supervision.

Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages.

Excellent organizational, interpersonal and communication skills (oral and written).

Ability to take feedback constructively and consider the viewpoints of others.

Operate in Computer systems and the ability to enter data in Excel Safe databases.

Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

Ability to work overtime as needed.

Physical Environment and Requirements

Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.

Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.

Employee must be able to occasionally lift and/or move up to 50 pounds.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees.

We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaposter.pdf

Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)

Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].

Our values define who we are. They are the fundamental beliefs of our organization and guide our actions and behavior. They influence the way we work with each other, the way we serve our clients, and the way we engage with our communities. Supporting patient health and enhancing the quality of life for animals are our guiding principles. Our promise is to provide the healthcare marketplace with a steady supply and broad portfolio of branded and generic specialty injectables. American Regent, Inc., a Daiichi Sankyo Group Company, is a top-10 injectable manufacturer. For over 50 years, we have been developing, manufacturing, and supplying high-quality generic and branded injectables for healthcare providers and veterinarians across the United States and Canada. For 20 years, American Regent has been a leader in IV iron therapy and we supply two of the top-selling brands in the US today. For over 30 years, we have supplied the leading joint health products for horses and dogs. We have locations in New York, Ohio, and California and sales territories nationwide.